Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04506112
Status:
WITHDRAWN
Last Update Posted:
2023-05-10
First Post:
2020-08-05
Brief Title:
Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator leaving institution Aim 3 was not initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims are to 1 optimize the Transdiagnostic Sleep and Circadian Intervention TranS-C for delivery to Veterans in cardiac rehabilitation 2 test and refine the adapted TranS-C treatment manual and protocol and 3 conduct a pilot randomized trial to establish the feasibility acceptability and plausibility of the intervention protocol and study procedures
Detailed Description:
Aim 1 will involve formative work to optimize the TranS-C manual and protocol for delivery in Cardiac Rehabilitation with input from Veterans and provider stakeholders Aim 2 will involve a preliminary test and refinement of the adapted TranS-C manual and protocol with a small sample of Veterans who are participating in cardiac rehabilitation and report sleep disturbance andor sleep-related impairment Aim 3 will involve a pilot randomized trial to establish the feasibility acceptability and plausibility of the intervention protocol and study procedures Veterans in cardiac rehabilitation with sleep disturbance andor sleep-related impairment will be randomized to TranS-C Usual Care or Usual Care Treatment satisfaction will be assessed at 3-months sleep disturbance and sleep-related impairment disability and functioning and health-related quality of life will be assessed at baseline 3-months and 6-months to determine measure responsiveness and provide preliminary insight into treatment effects
Of note information provided in this entry eg design eligibility criteria outcomes etc pertains only to Aim 3 which includes the pilot randomized trial Consistent with Stage I of the NIH stage model of behavioral intervention development research results from Aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in Aim 3
Of note information provided in this entry eg design eligibility criteria outcomes etc pertains only to Aim 3 which includes the pilot randomized trial Consistent with Stage I of the NIH stage model of behavioral intervention development research results from Aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in Aim 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX003393 | REGISTRY | Department of Veterans Affairs | None |